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In clinical trials, the most common adverse events with OraVerse (phentolamine mesylate) vs. control were post procedural pain (6% vs. 6%), injection site pain (5% vs. 4%), tachycardia (5% vs. 6%), bradycardia (2% vs. 0.3%) and headache (3% vs. 4%). Following parenteral use of phentolamine in non-dental indications, myocardial infarction and cerebrovascular spasm and occlusion have been reported, usually in association with marked hypotensive episodes producing shock-like states. Although such effects are uncommon with OraVerse, clinicians should be alert to the signs and symptoms of tachycardia and cardiac arrhythmias, particularly in patients with a history of cardiovascular disease, as these symptoms may occur with the use of phentolamine or other alpha-adrenergic blocking agents.
- Additional information
- OraVerse is the first and only local anesthesia reversal agent
- In clinical trials, the median time to recovery of normal sensation in the upper lip was 50 minutes for OraVerse patients vs. 133 minutes for the control group and in the lower lip was 70 minutes for OraVerse patients vs. 155 minutes for the control.
- In clinical trials, OraVerse patients were more quickly able to smile, speak, drink normally and minimize drooling.
- Market research shows 88% of patients may be interested in receiving a product like OraVerse1